Improved cardiometabolic risk factors in Japanese patients with type 2 diabetes treated with ipragliflozin:a pooled analysis of six randomized, placebo-controlled trials

Endocrine journal

Taishi Sakatani¹  Atsunori Kashiwagi² 

[1] Astellas Pharma Inc., Chuo-ku, Tokyo 103-8411, Japan;Kusatsu General Hospital, Kusatsu, Shiga 525-8585, Japan

关键词: Ipragliflozin;    Cardiometabolic risk factors;    Type 2 diabetes mellitus;    Pooled analysis;    Liver function;   

DOI  :  10.1507/endocrj.EJ17-0491

学科分类：内分泌与代谢学

来源: Japan Endocrine Society

【 摘 要 】

To examine differential improvements among cardiovascular risk factors in response to treatment with ipragliflozin in Japanese type 2 diabetes mellitus (T2DM) patients, we conducted a pooled analysis of six randomized, double-blind trials of Japanese T2DM patients who received ipragliflozin 50 mg/day or placebo and had patient-level data for cardiometabolic risk parameters. Risk factors included glycated hemoglobin (HbA1c), body weight, homeostatic model assessment for insulin resistance and beta-cell function (HOMA-R and HOMA-beta, respectively), systolic blood pressure, fasting serum insulin concentrations, and the concentration of uric acid, lipids, and liver enzymes from baseline to end of treatment (EOT; 12–24 weeks). The primary endpoint of each trial was the change in HbA1c from baseline to EOT. Changes in risk factors from baseline to EOT were compared between ipragliflozin-treated and placebo groups, and between two subgroups (high- and low-risk groups for each parameter). All parameters, except low-density lipoprotein cholesterol (LDL-C) and non high-density lipoprotein cholesterol (non HDL-C), improved significantly in the ipragliflozin group. Subgroup analysis revealed a significantly greater improvement in the high-risk group versus low-risk group in HbA1c, HOMA-R, HOMA-beta, aspartate transaminase, alanine transaminase, and gamma-glutamyltransferase, but not in any of the lipid parameters or blood pressure. Liver function improvement in the ipragliflozin group was significantly correlated with changes in body weight, HbA1c, HOMA-beta, and HOMA-R. This analysis demonstrated that, in Japanese T2DM patients, ipragliflozin 50 mg/day was associated with improvements in cardiometabolic risk factors, except for LDL-C and non HDL-C.

【 授权许可】

Unknown